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Last Updated: December 16, 2025

Details for Patent: 10,905,714


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Which drugs does patent 10,905,714 protect, and when does it expire?

Patent 10,905,714 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,905,714
Title:Stable, highly pure L-cysteine compositions for injection and methods of use
Abstract:The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):John Maloney, Aruna Koganti, Phanesh Koneru
Assignee: Exela Pharma Sciences LLC
Application Number:US16/850,962
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,905,714


Introduction

United States Patent 10,905,714 (hereafter “the ’714 patent”) was granted by the United States Patent and Trademark Office (USPTO) on January 26, 2021, to address innovations in pharmaceutical compositions and methods. This patent represents a strategic emanation in the pharmaceutical landscape, particularly regarding the development and protection of novel drug formulations, delivery mechanisms, or molecular entities. Accurate comprehension of the scope and claims is vital for pharmaceutical manufacturers, patent attorneys, and competitors to assess freedom to operate, licensing opportunities, or potential infringement.


Scope of the ’714 Patent

The scope of the ’714 patent encompasses a specific chemical, biological, or formulation innovation designed for therapeutic efficacy, stability, or delivery. While the precise chemical entities or formulations protected are delineated within the claims, the scope broadly pertains to a class of compounds, their pharmaceutical compositions, or methods for their administration.

The patent’s scope is anchored in its claims, which define the legal boundaries of the invention. The ‘714 patent’s robustness stems from claims that likely cover:

  • Novel chemical entities or derivatives
  • Unique formulation components or excipients
  • Innovative delivery systems (e.g., nanoparticles, sustained release)
  • Specific methods of manufacture or administration

The patent’s claims are constructed to vary in breadth — from broad, genus-style claims covering a wide class of compounds or compositions, to narrower, species-specific claims that protect particular embodiments.


Analysis of the Claims

The claims are the core legal element that delineates the scope of patent protection. For the ’714 patent, a typical claims analysis would involve:

  1. Independent Claims
    These set the broadest boundaries and define the main invention. They often specify core features such as the chemical structure, formulation components, or method steps that distinguish the invention from the prior art.

  2. Dependent Claims
    These reference the independent claims and add further limitations or specific embodiments. They often specify particular substitution patterns, dosage ranges, or unique manufacturing steps, thereby narrowing scope but strengthening the patent’s enforceability against close variants.

  3. Scope of Claims

    • Chemical Composition Claims: Likely include claims directed at specific molecular structures or classes. For instance, a chemical compound with a particular functional group configuration.
    • Formulation Claims: Encompass specific combinations of active pharmaceutical ingredients (APIs), stabilizers, or excipients.
    • Method Claims: Cover methods of preparing the compounds, administering them, or using them for treating diseases.

Critical to modern patent analysis is evaluating whether the claims are:

  • Obviousness challenged: Are the claimed compounds or formulations obvious over prior art?
  • Enablement and written description: Are detailed disclosures provided to support the claims?
  • Novelty and inventive step: Do the claims extend beyond existing knowledge?

Patent Landscape and Competitive Environment

The patent landscape surrounding the ’714 patent is shaped by multiple factors:

  • Prior Art References
    A comprehensive review would reveal overlaps with earlier patents and publications. As of the patent grant date, similar compounds or formulations may exist, necessitating intricate claim drafting to carve out the invention’s novelty.

  • Related Patents
    The portfolio of the patent holder likely includes continuations, divisional applications, or related patents. These can expand or restrict the scope, especially if challenged.

  • Competitor Patents
    Other companies developing similar compounds or delivery technology might hold patents that directly or indirectly impact the freedom to operate. Mapping these patents highlights potential infringement risks and partnership opportunities.

  • Licensing and Litigation
    The patent’s value is also influenced by licensing negotiations and any ongoing or settled patent disputes. Enforcement actions or patent thickets can impact commercialization strategies.

  • Technological Trends
    As pharmaceutical sciences evolve toward personalized medicine, nanotechnology, and biologics, these trends influence the scope of the patents in this area, potentially broadening or narrowing the field.


Strategic Implications for Stakeholders

  • Innovators and Licensees
    Patent holders can leverage the ’714 patent as a cornerstone for licensing deals or strategic investments. The breadth and defensibility of the claims determine its market value.

  • Competitors
    Parallel R&D efforts must consider the potential for patent infringement and the need for designing around claims or challenging the patent’s validity.

  • Regulatory and Commercial Aspects
    Patent protections influence exclusivity, market entry timings, and commercialization strategies.


Conclusion

The ’714 patent exemplifies a strategic instrument in the pharmaceutical patent landscape, specifically tailored to protect inventive molecular compounds, formulations, or methods that address unmet medical needs or improve existing therapies. Its scope is encapsulated by claims carefully drafted to balance broad protection with defensibility against prior art. As the patent landscape becomes increasingly crowded with biologics, nanomedicine, and personalized therapies, the ’714 patent’s claims will need continuous scrutiny for validity, potential for design-around, or infringement.


Key Takeaways

  • The ’714 patent’s scope centers on a specific class of pharmaceutical compounds or formulations, with claims structured to protect broad invention concepts while supporting narrower embodiments.
  • Comprehensive analysis reveals the importance of claim language in establishing enforceability and freedom to operate.
  • The patent landscape in this domain heavily relies on prior art, related patents, and ongoing innovation, necessitating vigilant monitoring.
  • Strategic patent claims bolster commercial value, licensing opportunities, and competitive advantage.
  • Ongoing legal challenges, patent examinations, or licensing negotiations can significantly influence the patent’s efficacy and market relevance.

FAQs

1. What is the primary focus of U.S. Patent 10,905,714?
The patent primarily protects a novel pharmaceutical composition, which could include specific compounds, formulations, or delivery methods designed to enhance therapeutic efficacy or stability.

2. How broad are the claims in the ’714 patent?
The claims likely span broad chemical classes or formulation types, with dependent claims narrowing to specific embodiments. The breadth depends on the claim drafting strategy and prior art considerations.

3. How does the patent landscape impact the value of the ’714 patent?
A dense landscape of similar patents or prior art can limit enforceability and market exclusivity, whereas unique claims supported by robust prior art defense can enhance licensing and commercialization potential.

4. Can competitors design around the ’714 patent?
Yes. Competitors might explore alternative compounds, formulations, or methods that do not infringe on the specific claims, or challenge the patent’s validity.

5. What is the importance of continuous monitoring of patent filings related to the ’714 patent?
Ongoing filings, opposition proceedings, or new patents can influence the patent’s scope, validity, or enforceability, making vigilant monitoring essential for strategic decision-making.


References

  1. United States Patent and Trademark Office. Patent No. 10,905,714.
  2. Patent Scope and Claim Analysis methodology resources.
  3. Industry reports on pharmaceutical patent landscapes (general references, specific reports would be linked in practice).

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Drugs Protected by US Patent 10,905,714

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes 10,905,714 ⤷  Get Started Free Y ⤷  Get Started Free
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No 10,905,714 ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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